The testing and certification of health IT tools is an important part of the adoption of EHR technology across the healthcare industry. The Office of the National Coordinator for Health IT (ONC) has held the chief responsibility for the certification of EHR systems and health IT tools.

ONC reports that one of its goals is to improve the testing and certifying of health IT tools and published a Federal Register notice on June 9. This notice allows for the National Coordinator to offer more flexibility in accepting test procedures, test capabilities, and data “developed by any person or entity for approved use.”

The reasoning behind the publication of the notice was due to feedback from healthcare industry stakeholders. The feedback involved improving testing efficiency by allowing the inclusion of industry-led testing and certification within the ONC Certification Program.

This news will allow for health IT vendors, developers, and other entities to submit data, test procedures, and test tools to be considered for inclusion within the Health IT Certification Program.

“We are excited about the potential of leveraging community supplied tools because there is no limit to the number that can be submitted and we believe that having more testing flexibility will help the program maximize the efficiencies already created and operational-proven by health IT developers,” ONC reported.

This will create more flexibility and opportunity for those looking for alternative testing resources when it comes to the certification of their health IT tools. Those interested in submitting test tools, test procedures, or test data to be addressed by ONC representatives can do so via the emailonc.certification@hhs.gov.

“The National Coordinator is open to approving test procedures, test tools, and test data that meet the outlined approval requirements above for an applicable adopted certification criterion or criteria,” theDepartment of Health and Human Services (HHS) stated in a document. “By way of this document, we strongly encourage persons or entities to submit such test procedures, test tools, and test data to ONC if they believe such procedures, tools, and data could be used to meet ONC’s certification criteria and testing approval requirements. We also note that there is no programmatic prohibition on the approval of multiple test procedures, test tools, and test data for a certification criterion or criteria.”

Other changes that have been included among federal agencies regarding the adoption of health IT tools include the modification to Stage 2 Meaningful Use requirements. The modifications proposed by the Centers for Medicare & Medicaid Services (CMS) will last between the years 2015 to 2017.

Providers should pay attention to all changes with meaningful use requirements as well as alterations with certification of health IT tools in order to receive financial incentives under the EHR Incentive Programs established by CMS.

All of these changes are reforming the healthcare industry as a whole and providers should expect ongoing policy revisions across the nation in efforts to improve the quality of healthcare services, better population health outcomes, and lower rising costs.

EMRs can be customized to some extent today, but not that much. Providers can create interfaces between their EMR and other platforms, such as PACS or laboratory information systems, but you can’t really take the guts of the thing apart. The reality is that the EMR vendor’s configuration shapes how providers do business, not the other way around.

This has been the state of affairs for so long that you don’t hear too much complaining about it, but health IT execs should really be raising a ruckus. While some hospitals might prefer to have all of their EMR’s major functions locked down before it gets integrated with other systems, others would surely prefer to build out their own EMR from widgetized components on a generic platform.

Actually, a friend recently introduced me to a company which is taking just this approach. Ocean Informatics, which has built an eHealth base on the openEHR platform, offers end users the chance to build not only an EMR application, but also use clinical modules including infection control, care support, decision support and advanced care management, and a mobile platform. It also offers compatible knowledge-based management modules, including clinical modeling tools and a clinical modeling manager.

It’s telling that the New South Wales, Australia-based open source vendor sells directly to governments, including Brazil, Norway and Slovenia. True, U.S. government is obviously responsible for VistA, the VA’s universally beloved open source EMR, but the Department of Defense is currently in the process of picking between Epic and Cerner to implement its $11B EMR update. Even VistA’s backers have thrown it under the bus, in other words.

Given the long-established propensity of commercial vendors to sell a hard-welded product, it seems unlikely that they’re going to switch to a modular design anytime soon. Epic and Cerner largely sell completely-built cars with a few expensive options. Open source offers a chassis, doors, wheels, a custom interior you can style with alligator skin if you’d like, and plenty of free options, at a price you more or less choose. But it would apparently be too sensible to expect EMR vendors to provide the flexible, affordable option.

That being said, as health systems are increasingly forced to be all things to all people — managers of population health, risk-bearing ACOs, trackers of mobile health data, providers of virtual medicine and more — they’ll be forced to throw their weight behind a more flexible architecture. Buying an EMR “out of the box” simply won’t make sense.

When commercial vendors finally concede to the inevitable and turn out modular eHealth data tools, providers will finally be in a position to handle their new roles efficiently. It’s about time Epic and Cerner vendors got it done!

The Office of the National Coordinator for Health IT (ONC) released the 2015 Interoperability Standards Advisory earlier this year and opened up the public comment period until Friday, May 1, 2015 at 5:00 pm ET. This advisory focused on determining the best EHR interoperability standards and implementation specifications for the healthcare industry throughout the nation.

ONC hopes to develop a single public list of standards that can reach clinical interoperability of medical information. On May 1, the Healthcare Information and Management Systems Society (HIMSS) announced that the organization sent a letter to Karen DeSalvo, MD, MPH, MSc, National Coordinator for Health Information Technology at the Office of the National Coordinator (ONC), with comments on the 2015 Interoperability Standards Advisory.ONC

HIMSS hopes to work with ONC to further identify and develop effective EHR interoperability standards and implementation specifications. Currently, HIMSS commented in the letter its support for a variety of the standards that would push forward health IT interoperability on a nationwide scale. The organization also supports ONC’s outline in the Interoperability Roadmap of publishing updated EHR interoperability standards on a yearly basis.

HIMSS also commented on the importance of developing a united set of best available EHR interoperability standards that would bring about data aggregation and best practices. This set of standards would lead to improved quality of care and patient health outcomes, HIMSS representatives stated in the letter.

“Through the use of EHRs, clinical documentation not only serves to record individual patient experiences but, if the data are collected and reported in a standardized fashion, they can also be aggregated to discern best practices in clinical care which will ultimately lead to improved care and outcomes,” the HIMSS letter states. “The ONC 2015 Interoperability Standards Advisory should represent a cohesive set of standards and terminologies that, when used together, will enable the ability to share and compare quality data.”

Some vital areas that would benefit from better analysis of this data are clinical research, quality audits, and clinical care. HIMSS also asks ONC to include a column for emerging standards to act as supplement to the already existing EHR interoperability standards as well as a column for value sets.

HIMSS recommended some key features that should be incorporated in the EHR interoperability standards and implementation specifications. Additionally, ONC’s 2015 Interoperability Standards Advisory lacked privacy and security guidelines needed for effective healthcare data exchange that protects patient information. HIMSS offered a series of privacy and security standards that ONC can include in its final advisory. These include audit log, authentication, and risk assessment among others. HIMSS worked with other stakeholders to develop these security standards and hopes ONC will include the information once it releases the finalized document.

In general, HIMSS and ONC are dedicated to expanding health information exchange across the country in order to ensure better quality of care and reduced healthcare costs.

Bruce Eckert, the national practice director at Beacon Partners Healthcare Management Consultants, leads the strategy, business intelligence, and meaningful use teams at the Weymouth, Mass.-based consulting firm, which recently merged with the New York-based KPMG.

In a meeting at the McCormick Place Convention Center in Chicago with HCI Editor-in-Chief Mark Hagland on Monday, April 13 during the HIMSS Conference, Eckert responded to Hagland’s questions about meaningful use and other issues facing the industry.

Asked about the proposed change to Stage 2 meaningful use requirements that would change the previous requirement that eligible providers get 5 percent of their patients to view, download, and transmit their health information to requiring that only one patient do so—with the anticipation that 25 percent of patients must then view, download and transmit under Stage 3, he admitted that he was as puzzled as everyone else seemed to be, and expressed the hope that federal officials at the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) would clarify that point soon.

Below are additional excerpts from their Monday interview.

What do you think of the Stage 3 proposed rule overall?

I like the structure, in that they're very compressed things down to 8 measures, and the menu sets are embedded in the measures. And they're collecting higher level data than before. So it's a nice framework. And we just did a HIMSS focus group around patient engagement. We had 12 people. Not universally but many are having challenges getting patients to use portals. Not so many problems with secure messaging, because the patients find value in it. So what the patients find value in, works well.

One of the challenges, it seems, continues to be timelines. Your thoughts?

Clearly in my mind, CMS is still trying to recover from the 2014 vendor certification debacle, with a lack of time to catch up. And they're setting up possibly the same timeline compression on the vendor side again coming into Stage 3. But I do think we've learned something from the 2014 CEHRT debacle. And perhaps this flexibility will help, because it might provide some breathing room for organizations.

You’ve just finished moderating a focus group with a diverse group of healthcare IT leaders. What kinds of concerns did they talk about?

They talked about things like appointment reminders, and push messaging for diagnostic results. And they didn't seem to think the patient education element in meaningful use would be difficult.

Overall, how did they perceive the challenges of Stage 3?

Most said it would be challenging, but doable, as long as they get the 2015 CEHRT in, in time. There's nothing really revolutionary in Stage 3, to be honest. And though it's not specifically on there, I think we'll see widespread adoption of PHRs, because a lot of the requirements wrap around that.

Who will manage the personal health record has long been a practical issue in the industry. Has that question been resolved?

Not entirely, but there will be third parties. And if you look at how HealthKit and HealthVault are architected, they really do give the patient the power. So I really do see third party vendors doing this. The issue would be whether they would be considered business associates under HIPAA. But if they add data in, the providers, then they would be covered. But I’ll predict that PHRs will be widely adopted under Stage 3. And I think we're approaching the end of the HIE [health information exchange] era. I attended the ONC's annual meeting in February. And they had a panel with all the former national coordinators together. And one of them said, the honest truth we have to face is that there's no business model for HIEs. That's evidence number one And look at the way meaningful is going. CMS is effectively supporting DIRECT protocols. I can see that whole infrastructure development—from regional HIEs to state HIEs to some anticipated nationwide infrastructure, simply not coming to fruition in the end. I think we're going to see the end of HIEs.

What should our audience be thinking about in the next few years?

Having more data, better data, and the ability to analyze data, will be key. Those organizations that manage and analyze data better will succeed, those that don't, won't. And we really moving in the direction of intensive data consumption, analytics, and management going forward, partly because of the impact of meaningful use.

EHR interoperability has been the topic of discussion among many healthcare stakeholders in recent months. On a national level, federal agencies like the Office of the National Coordinator for Health IT (ONC) are gearing toward advancing secure and effective healthcare data exchange.

While EHR interoperability is a major goal among top stakeholders, there are alleged healthcare providers and health IT designers that may be participating in a practice called “information blocking.” On April 10, ONC released a Report to Congress on Health Information Blocking to address these concerns.

Health information blocking essentially takes place when individuals or organizations knowingly impede the sharing of electronic medical data. The report specifically states steps that the federal government can take to deter this practice and move toward nationwide data exchange.

This blockage of EHR interoperability goes against the ultimate goals of the EHR Incentive Programs. The amount of time and funds the federal government invested in the implementation of EHR systems and health IT tools may be in vain if health information blocking spreads across the country.

At this moment in time, it is difficult to pinpoint how much health information blocking is impeding healthcare data exchange among medical care entities. It is also a complex term to define, as some aspects of preventing the exchange of information could be related to ensuring patient privacy and data security.

Earlier this year, ONC released the Shared Nationwide Interoperability Roadmap to further advance the connection of EHRs and health IT systems in an attempt to share healthcare data across state borders. While the roadmap discussed the challenges associated with EHR interoperability, it set out specific steps developers and providers can take to meet this overarching goal and ultimately improve patient care.

ONC explains that there are certain individuals within the health IT industry that are incentivized toward managing health information in ways that interfere with its effective exchange across the medical sector. In order to overcome some of the issues around information blocking, ONC offers several suggestions.

First, it is beneficial to have greater transparency in the development processes of certified health IT products or services. ONC also recommends Congress to establish rulings that deter information blocking in the healthcare industry. When illegal business practices are uncovered, these individuals should also be immediately referred to appropriate law enforcement agencies.

ONC also encourages the federal government to continue collaborating with the public and private sectors in establishing new technologies that aim to improve interoperability of healthcare data across the country. The report also states that Congress could stimulate EHR interoperability by working with the Centers for Medicare & Medicaid Services (CMS) to discourage information blocking and reward medical organizations through payment incentives for successful EHR data exchange.

ONC believes that it is vital to overcome the issues surrounding information blocking in order to ultimately meet the major goals behind healthcare IT implementation and provider access of patient data. The federal government will need to address these problems in the coming years as the healthcare industry poises to expand health data exchange around the country.

With the vast amounts of data collected in the healthcare industry, providers, vendors, and other stakeholders are putting more focus into developing health information exchange (HIE) and greater EHR interoperability. The Office of the National Coordinator for Health IT (ONC) released a report to Congress – Update on the Adoption of Health Information Technology and Related Efforts to Facilitate the Electronic Use and Exchange of Health Information – to offer policy guidance on the best ways for optimizing health IT systems and supporting HIEs.

Ever since the federal government passed the Health Information Technology for Economic and Clinical Health (HITECH) Act, the number of hospitals and physician practices adopting EHR systems has grown substantially. Currently, more than half of hospitals have at least a basic EHR system in place while, in 2013, 48 percent of physicians had EHRs at their practice.

Additionally, eligible professionals and eligible hospitals across the country are participating in the Medicare and Medicaid EHR Incentive Programs. While there has been significant progress in implementing health IT, there are still barriers that are halting widespread health information exchange across healthcare organizations and vendor products.

For example, if an individual from Maine takes a vacation in Florida and experiences a patient encounter, their primary care provider from Maine would likely not be informed nor would be able to access the patient’s emergency care data.

The report states that some of the common barriers to EHR adoption and thereby challenges for expanding health information exchange include the cost of purchasing a system, loss of productivity, training difficulties, the costs of annual maintenance, and obstacles related to finding an EHR system that supports practice needs. Nonetheless, in 2013, eight in ten physicians were using an EHR system or planning to adopt one, according to an ONC data brief.

ONC explains in its report that some of the reasons health information exchange is lacking is due to inconsistent structure, format, and even medical vocabulary used across different EHR systems and vendor products. ONC outlines key actions the Department of Health and Human Services (HHS) will need to take to improve nationwide EHR interoperability. These actions include:

Creating new standards that are integral to the development of a connected healthcare system

Requiring more staff in the health IT workforce to support the implementation of electronic records

Improving the sharing of data among providers and public health agencies

Collaborating, advising, and sharing studies with states, communities, and providers to stimulate IT solutions in the healthcare field

Driving patient engagement with their health information

ONC hopes that Stage 2 Meaningful Use requirements will also catalyze a widespread data exchange network within the healthcare sector. By using these five strategies, HHS plans to further advance health information exchange and invest in health IT usability throughout the nation.

Even though the Stage 3 Meaningful Use proposed rule is now dominating the public dialogue about the EHR Incentive Programs, many healthcare providers are still struggling to meet Stage 2 Meaningful Use regulations. One of the key issues that concerns providers is the difficulty of increasing patient engagement and the use of patient portals.

Having patients be more aware and have more control over their own health is necessary to ensure better patient outcomes and quality of care. The Centers for Medicare & Medicaid Services (CMS) state on their website these intentions as their primary reason for emphasizing patient engagement in Stage 2 Meaningful Use requirements under the Medicare and Medicaid EHR Incentive Programs.

Stage 2 Meaningful Use calls for more patient-centered care that includes providing patients with access to download and view their electronic health information through portals. Additionally, providers are encouraged to send patient follow-up reminders and preventive care correspondence.

Providers will need to ensure that more than 5 percent of their patients access their data through patient portals and utilize secure messaging tools to speak with their physician. In order to assist providers in meeting these requirements, the Office of the National Coordinator for Health IT (ONC) provides a fact sheet to assist in the implementation of patient portals.

First, ensuring a portal is user-friendly and engaging is key in meeting this requirement under Stage 2 Meaningful Use. Transitioning toward using this technology during clinical examinations or treatments may improve decision-making, patient-physician communication, and self-care support.

Often, the older population may not be as tech-savvy with regard to accessing their health data through a patient portal. ONC suggests training these patients to use the tools and services available through a portal.

Some key actions that providers should take to improve patient engagement is to implement proactive and engaging features as well as promote and expedite portal use. There are a variety of benefits providers gain from portals such as efficient and effective communication channels with patients, greater self-care initiative from patients, and higher patient satisfaction.

When developing a patient portal, it is useful to have interactive features that are relevant to patient needs. A portal should go beyond merely scheduling features and a method for displaying lab results. Incorporating decision tools and secure messaging capabilities will catalyze the regular use of patient portals. For additional expertise in implementing patient portals, the ONC fact sheet recommends providers to seek the assistance of regional extension centers (RECs).

Currently, patient portals are expanding not only nationwide but also across the globe. A press release from Frost & Sullivan emphasizes the high adoption rate of patient portals in Africa.

“The ability of patient portals’ to optimize the operational and financial efficiency of healthcare providers and payers by leveraging time-saving technologies is a key purchasing factor,” Frost & Sullivan Healthcare Research Analyst Saravanan Thangaraj said in the company press release. “Further, it can ease some of the tedious and monotonous administrative, as well as data-entry, tasks that consume hospital resources. Patient portals also eliminate the need for additional staff and postage by enabling patients to perform functions online.”

A high-level view of the direction being taken by electronic health records in the U.S. comes from a recent data brief released by the Office of the National Coordinator. Their survey of physician motivations for adopting EHRs turns up some puzzling and unexpected findings. I’ll look at three issues in this article: the importance of Meaningful Use incentives and penalties, the role of information exchange, and who is or is not adopting EHRs.

Incentives and Penalties The impact of the Meaningful Use bribes–sorry, I meant incentive payments–in the HITECH act are legendary: they touched off a mad rush to adopt technology that had previously aroused only tepid interest among most physicians, because they found the EHRs outrageously expensive, saw no advantage to their use, or just didn’t want to leave the comfort zone of pen and paper. The dramatic outcome of Stage 1, for instance, can be seen in the first chart of this PDF.

This month’s data brief reconfirms that incentives and penalties played a critical role during the period that Meaningful Use has been in play. In the brief’s Figure 3, incentives and penalties topped the list of reasons for adopting records, with nothing else coming even close (although the list was oddly chosen, leaving out credible reasons such as “EHRs are useful”).

The outsized role payments play is both strange and worrisome. Strange, because the typical $15,000 paid per physician doesn’t even start to cover the costs of converting from paper to an EHR, or even from one EHR to another. Worrisome, because the escalator (a favorite metaphor of former National Coordinator David Blumenthal) on which payments put physicians is leveling off. Funding in the HITECH act ends after Stage 3, and even those payments will be scrutinized by the incoming budget-conscious Congress.

The ONC knows full well that they have to cut back expectations as payments dry up, although penalties from the Center for Medicare & Medicaid Services can still provide some leverage. Already, the recent House budget has level-funded the ONC for next year. Last summer’s reorganization of the ONC was driven by the new reality. Recent initiatives at the ONC show a stronger zeal for creating and urging the adoption of standards, which would be consistent with the need to find a role appropriate to lean times.

Health Information Exchange I am also puzzled by the emphasis this month’s data brief puts on health information exchange. Rationally speaking, it would make perfect sense for physicians to ramp up and streamline the sharing of patient data–that’s exactly what all the health care reformers are demanding that they do. Why should somebody ask a patient to expose himself to unnecessary radiation because an X-Ray hasn’t been sent over, or try to treat someone after surgery without knowing the discharge plan?

And that’s probably why, after taking hundreds of millions of dollars from governments, the heavy-weight institutions called Health Information Exchanges have repeatedly thrown in the towel or been left gasping for breath. At least two generations of HIEs have come and gone, and the trade press is still searching for their value.

So I’m left scratching my head and asking: if doctors adopt EHRs for information exchange, are they getting what they paid for? Redemption may have arrived through the Direct project, an ONC-sponsored standard for a low-cost, relatively frictionless form of data exchange. Although the original goal was to make HIE as simple as email, the infrastructure required to protect privacy imposes more of a technical burden. So the ONC envisioned a network of Health Information Service Provider (HISP) organizations to play the role of middleman, and a number are now operating. According to Julie Maas of EMR Direct, nearly half a million people were using Direct in July 2014, and the number is expected to double the next time statistics are collected next February.

So far, although isolated studies have shown that HIEs improve outcomes and reduce costs, we haven’t seen these effects nationwide.

What Hinders Adoption Some of the most intriguing statistics in the data brief concern who is adopting EHRs and what holds back others from doing so. The main dividing line is simply size: most big organizations have EHRs and most small ones don’t.

Americans have trouble feeling good about consolidation in any field. We’re nostalgic for small-town proprietors like the pharmacist in the movie It’s a Wonderful Life. We forget that the pharmacist in that movie nearly killed someone by filling a prescription incorrectly. In real life, large organizations can pursue quality in a host of ways unavailable to individuals.

One interesting finding in the data brief is that rural providers are adopting EHRs at the same rate as urban ones. So we can discard any stereotypes of country hick doctors letting teenagers set up the security on their PCs.

Lack of staff and lack of support are, however, major barriers to adoption. This is the last perplexing question I take from the data brief. Certainly, it can be hard to get support for choosing an EHR in the first place. (The Meaningful Use program set up Regional Extension Centers to partially fill the gap.) But after spending millions to install an EHR, aren’t clinicians getting support from the vendors?

Support apparently is not part of the package. Reports from the field tell me that vendors install the software, provide a few hours of training, and tip their hats good-bye. This is poetic justice toward physicians, who for decades have sent patients out weak and groggy with a prescription and a discharge sheet. Smart organizations set aside a major percentage of their EHR funding to training and support–but not everybody knows how to do this or has grasped the need for ongoing support.

I certainly changed some of my opinions about the adoption of EHRs after reading the ONC data brief. But the statistics don’t quite add up. We could use some more background in order to understand how to continue making progress.

The movement toward EHR interoperability is sought by the federal government and certain patient advocacy groups that believe it will lead to improved quality of healthcare, better outcomes, and lower costs. With the Office of the National Coordinator (ONC) releasing an Interoperability Roadmap and issuing a report to Congress addressing the problems of information blocking, it is clear that the healthcare sector will be moving toward greater EHR interoperability and less restrictive health data exchange systems.

After ONC issued its report on information blocking in which EHR vendors were accused of charging additional fees for healthcare providers looking to access patient medical data outside of their facility, Epic Systems was one vendor that decided to drop its fees for exchanging patient data with non-Epic EHR system users. The Milwaukee Business Journal reported Epic System’s fees will be excluded until 2020.

Previously, Epic Systems charged $2.35 for every patient record accessed that wasn’t part of its EHR system. Removing these charges will be a big boost to EHR interoperability. Epic will also be taking part in the Carequality project, which is meant to develop effective health data exchange networks that assist in the sharing of medical information throughout the country.

While EHR interoperability is the name of the game for ONC, other federal agencies, and many healthcare providers, there are certain entities and individuals that do not support the seamless sharing of data. This was clearly seen in the public comments provided to ONC after the release of the Interoperability Roadmap.

“I have many issues with EHRs and interoperability – privacy is one of them. Privacy is a person’s right and this seems to be taken away with EHR interoperability,” wrote one stakeholder. “It allows nationwide access by innumerable people, which is unacceptable.”

Wayne Johnson, a retired Senior Project Manager, wrote to ONC: “I strongly urge you to vote against the proposed implementation of a National Medical Records System, an intrusive, non-secure storage and retrieval system designed to store and track the private medical data of US citizens, citizens who rightfully expect their personal information and effects to be secure from government inspection. I hold a Master’s of Science in software engineering, and I guarantee that the database system you intend to build, regardless of your intentions for security, will be compromised. Unlawful access to the private medical information stored in the system will be achieved. There is no such thing as an absolutely secure networked system.”

The guide has been updated to become more user-friendly and geared toward smaller medical practices and healthcare organizations that are addressing privacy and security measures across their facility, according to The National Law Review. While targeting small providers, the guide is also applicable to organizations of all sizes.

Some of the areas ONC focuses on includes identifying when patient authorizations are needed to disclose protected health data, the key questions providers need to ask their EHR vendors about security, and how to develop a security management program that will cover the privacy and security requirements under the Medicare and Medicaid EHR Incentive Programs.

While EHR interoperability remains vital for strengthening the healthcare industry as a whole, providers will need to focus on privacy and security measures to allay the fears of their patients.

Interoperability in health care is all the rage now. After publishing a ten year interoperability plan, which according to the Federal Trade Commission (FTC) is well positioned to protect us from wanton market competition and heretic innovations, the Office of the National Coordinator for Health Information Technology (ONC) published the obligatory J’accuse report on information blocking, chockfull of vague anecdotal innuendos and not much else. Nowadays, every health care conversation with every expert, every representative, every lobbyist and every stakeholder, is bound to turn to the lamentable lack of interoperability, which is single handedly responsible for killing people, escalating costs of care, physician burnout, poverty, inequality, disparities, and whatever else seems inadequate in our Babylonian health care system.

When you ask the people genuinely upset at this utter lack of interoperability, what exactly they feel is lacking, the answer is invariably that EHRs should be able to talk to each other, and there is no excuse in this 21st iCentury for such massive failure in communications. The whole thing needs to be rebooted, it seems. After pouring tens of billions of dollars into building the infrastructure for interoperability, we are discovering to our dismay that those pesky EHRs are basically antisocial and are totally incapable or unwilling to engage in interoperability. The suggested solutions range from beating the EHRs into submission to just throwing the whole lackluster lot out and starting fresh to the tune of hundreds of billions of dollars more. When it comes to sacred interoperability, money is not an object. It’s about saving lives.

Every EHR vendor flush with cash from the Meaningful Use bonanza is preparing to take its unusable product to the next level, machine interoperability is shaping up to be the belle of the ball. A simple minded person may be tempted to wonder why people who, for decades, manufactured and sold EHRs that don’t talk to each other, are all of a sudden possessed by interoperability fever. The answer is deceptively simple. After exhausting the artificially created market for EHRs, these powerful captains of industry figured out that extracting rents for machine interoperability is the next big thing.

The initial pocket change comes from selling machine interoperability to their current bewildered (or stupefied) clients, and to less fortunate EHR vendors. But the eventual windfall will not come from the health care delivery system or the hapless patients caught in its web. How much do you think access to a national and hopefully global network of just-in-time medical and personal data is worth to, say, a pharmaceutical company giant? How about life insurance, auto insurance, mortgage, agribusiness, cosmetics, homeland security, retail, transportation? Google built an empire by piecing together disjointed bits of personal data flowing through its electronic spider webs. What do you think can be built by combining everything Google knows with everything your doctor knows and everything you know about yourself?

Machine interoperability is not about patient care in the here and now. Interoperability is not about ensuring that all clinicians have the information they need to treat their patients, or that patients have all the information they need to properly care for themselves. Interoperability is about enriching a set of interoperability infrastructure and service providers and about electronic surveillance of both doctors and their patients. Machine interoperability is about control, power and boatloads of hard cash.

For example, if you are hospitalized, it makes sense that your primary care doctor should know that you are (not in the past tense), and when you are discharged, he or she should be appraised of what transpired during your hospital stay. In the old days, before the advent of hospitalists, this could be assumed. Today, thanks to more efficient division of labor, not so much. If the government was genuinely concerned about smooth transitions of care, it would mandate that upon discharge, hospitals must provide all pertinent information to the primary care doctor, and the patient, by any means necessary. If this meant that a piece of paper is stapled to the patient’s robe, and that the hospital employs an army of delivery drones for the purpose, so be it. Eventually, hospitals, which are big businesses, would come up with the most cost effective and efficient way to be compliant with the law.

That’s not how things currently work or how they are envisioned to work. Discharge summaries have a mandated format of structured data elements, complete with metadata, based on government approved standards that change with frightening regularity. Furthermore, to satisfy regulations, the summaries must be generated and transmitted electronically from one “certified” EHR to another, allowing for a host of intermediaries to access and collect said data or at the very least its metadata. Consulting with the PCP by phone for an hour doesn’t count. Sending the information from a non-certified software package doesn’t count. Printing and sending over information by special courier doesn’t even begin to count. Attempting to build a device that streams the information as it happens directly into the PCP medical record will get you excommunicated or burned at the stake.

If you refer a patient to cardiology service, and in a misguided senior moment decide to pick up the phone and talk to the cardiologist at length about this patient, it doesn’t count. If the cardiologist pens a concise and beautiful letter to you after she sees your patient, thanking you for the referral and summarizing her impressions and plan of care in proper English, it doesn’t count. The only thing that counts is a lengthy clinical summary containing all the sanctioned data elements sent from you to the cardiologist, copied in its entirety and returned from the cardiologist to you, hopefully with some indication about what happened during the consult. Having your EHRs talk to each other this way is considered interoperability. Whether you actually read the interoperated information is irrelevant. As long as the contents are captured by the network for other uses, it’s all good.

But wait, there is more. If you practice, say, in St. Louis, Missouri and work for a huge health system or somehow managed to string together a machine interoperable network with the twenty or so specialists you use on a regular basis and the four hospitals where you have admitting privileges, that’s not good enough. Nothing is good enough unless any research lab in Hopewell, New Jersey or Bangalore, India can discover you on the (inter)national interoperability network and request data about a patient you may have treated five years ago, and nothing will be good enough unless any app store developer in Cupertino, California can discover your patient and subsequently obtain her medical data once she downloads a free diet app from iTunes.

Are you “just” a patient eager to be “engaged” in your own care? Picking a doctor who will spend two hours with you listening carefully and explaining things you don’t understand, and who will give you his cellphone number in case you have more questions, doesn’t count. Getting a team of physicians together on a conference call to brainstorm about your mom’s options, doesn’t count. Building a long term relationship with your pediatrician and having her come see your sick kid at home because your car is in the shop and your toddler can’t keep any food down, and now the baby won’t stop crying, doesn’t even register on the interoperability radar. Nothing counts unless you log into a website or an app, accept the cookies, the tracking beacons, the small print, and then click on some buttons to verify that you are a “Never smoker”, or to peruse machine generated visit notes that even your doctors don’t read anymore.

Perhaps machine interoperability on a national scale is a wonderful thing, but so is having arugula in every fridge. There is absolutely no evidence that either one will improve health and/or reduce the price of care. Every dollar spent on national machine interoperability is a dollar that was previously used, or could be used, to provide medical care. Where did we find the moral fortitude to demand that people experience adverse outcomes at least three times before letting them have a slightly more expensive pill, while spending billions of dollars to incentivize the purchase of unproven and often failing technologies? If we are supposed to be parsimonious in our use of health care resources, if we are supposed to choose wisely in all other areas, where is the comparative effectiveness research showing that expensive machine interoperability on a grandiose global scale provides more value than cheaper and simpler localized or human mediated communications?

Add one doctor visit for every Medicare beneficiary for the next 8 years

Give primary care a 20% raise for the next 4 years

Double the number of residencies for the next 3 years

Educate 60,000 new primary care doctors from scratch

Buy an iPhone glucose monitor for every diabetic patient and an iPhone BP monitor for every hypertensive patient (no, I’m not a “technophobe”)

Put a brand new playground, a gym teacher and a home economics teacher in every elementary school in the U.S.

End homelessness in America

These are some of the things we could do with the billions of dollars spent on machine interoperability. Which has more value for our collective health? How did health care become a fully owned subsidiary of the computer industry? Who authorized this unholy acquisition and how much were those brokers paid? Have we forfeited our right to choose, or even know, how endless fortunes are steadily interoperating out of our treasury and into the hands of global technology firms? Publishing fuzzy ten year plans on obscure websites, so the Technorati can tweak them, doesn’t count. Publishing thousands of pages of regulations in the federal register, so interest groups can preview the fruits of their labor, doesn’t count either. Raiding public coffers to please friends and family and to curry political favors is hardly a disruptive innovation, so let’s just call it what it is.

Ever since the Medicare and Medicaid EHR Incentive Programs have been established, the adoption and implementation of EHR systems and other health IT products has been tremendous. The health IT sector in general has been expanding greatly over the last several years.

The Office of the National Coordinator for Health IT (ONC) reports that almost $700 million was invested in medical technologies during the first quarter of 2014, which shows an 87 percent growth when compared to the first quarter of 2013. Health IT products and mobile health applications are all leading the way in changing the way doctors and consumers interact across the healthcare continuum.Health IT Products

Nonetheless, ONC explains that even with the evident growth in the health IT sector, many startups are still challenged in acquiring pilot partners that will help develop their health IT systems and show that their product is effective for the industry. These pilot partners are necessary for acquiring the data needed to establish a health IT product as successful among potential investors and customers including healthcare systems, payers, and the patient community.

As such, ONC is looking to create stronger relationships to help innovators bring new health IT products to the market. ONC has announced a new challenge program: the Market Research and Development Pilot Challenge.

To participate in the challenge, health IT developers will need to work with host sites like hospitals, clinics, pharmacies, or laboratories to create pilot proposals. ONC will be offering $300,000 through a year-long commitment to truly develop new and revolutionary health IT products for the medical sector.

The funding will be distributed among six teams who will then initiate the pilot, collect a variety of data, evaluate the product, and distribute the results with ONC’s assistance. After six months, the teams will be expected to return an evaluation report about their findings. The very first steps to take, however, is to select the right team, create an overall plan, and prepare the pilot proposal.

For each team, ONC will first award $25,000 when the pilot teams are selected and then another $25,000 after the pilot development and evaluation period is completed. In addition to this challenge, ONC will also be initiating sessions around the nation to train the health IT startup community on federal regulations, privacy and security standards, payment reforms, and funding opportunities that will affect the outcome of their services or health IT products.

The forward push for increasing the number of health IT solutions among providers and medical systems leads a pathway toward sharing patient data quickly and efficiently across the healthcare continuum. The National Coordinator for Health IT Karen B. DeSalvo has spoken about the need for EHR interoperability and helped develop the ONC roadmap to reach this goal.

“We heard loudly and clearly that it was time to focus on interoperability as a priority and we articulated why the time is now to achieve the vision. First, as a nation, we have made significant progress in digitizing the care experience such that there is now data to be shared. Second, consumers increasingly expect and demand real-time access to their electronic health information,” DeSalvo stated. “Informed by your input and feedback we acted on this opportunity.”

The secure, appropriate, and efficient sharing of electronic health information is the foundation of an interoperable learning health system—one that uses information and technology to deliver better care, spend health dollars more wisely, and advance the health of everyone.

Today we delivered a new Report to Congress on Health Information Blocking that examines allegations that some health care providers and health IT developers are engaging in “information blocking”—a practice that frustrates this national information sharing goal.

Health information blocking occurs when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information. Our report examines the known extent of information blocking, provides criteria for identifying and distinguishing it from other barriers to interoperability, and describes steps the federal government and the private sector can take to deter this conduct.

This report is important and comes at a crucial time in the evolution of our nation’s health IT infrastructure. We recently released the Federal Health IT Strategic Plan 2015 – 2020 and the Draft Shared Nationwide Interoperability Roadmap. These documents describe challenges to achieving an interoperable learning health system and chart a course towards unlocking electronic health information so that it flows where and when it matters most for individual consumers, health care providers, and the public health community.

While most people support these goals, some individual participants in the health care and health IT industries have strong incentives to exercise control over electronic health information in ways that unreasonably interfere with its exchange and use, including for patient care.

Over the last year, ONC has received many complaints of information blocking. We are becoming increasingly concerned about these practices, which devalue taxpayer investments in health IT and are fundamentally incompatible with efforts to transform the nation’s health system.

The full extent of the information blocking problem is difficult to assess, primarily because health IT developers impose contractual restrictions that prohibit customers from reporting or even discussing costs, restrictions, and other relevant details. Still, from the evidence available, it is readily apparent that some providers and developers are engaging in information blocking. And for reasons discussed in our report, this behavior may become more prevalent as technology and the need to exchange electronic health information continue to evolve and mature.

There are several actions ONC and other federal agencies can take to address certain aspects of the information blocking problem. These actions are outlined in our report and include:

Proposing new certification requirements that strengthen surveillance of certified health IT capabilities “in the field.”

Proposing new transparency obligations for certified health IT developers that require disclosure of restrictions, limitations, and additional types of costs associated with certified health IT capabilities.

Working with the Centers for Medicare & Medicaid Services to coordinate health care payment incentives and leverage other market drivers to reward interoperability and exchange and discourage information blocking.

Helping federal and state law enforcement agencies identify and effectively investigate information blocking in cases where such conduct may violate existing federal or state laws.

Working in concert with the HHS Office for Civil Rights to improve stakeholder understanding of the HIPAA Privacy and Security standards related to information sharing.

While these actions are important, they do not provide a comprehensive solution to the information blocking problem. Indeed, the most definitive finding of our report is that most information blocking is beyond the current reach of ONC or any other federal agency to effectively detect, investigate, and address. Moreover, the ability of innovators and the private sector to overcome this problem is limited by a lack of transparency and other distortions in current health IT markets.

For these and other reasons discussed in our report, addressing information blocking in a comprehensive manner will require overcoming significant gaps in current knowledge, programs, and authorities. We believe that in addition to the actions above, there are several avenues open to Congress to address information blocking and ensure continued progress towards the nation’s health IT and health care goals.

Information blocking is certainly not the only impediment to an interoperable learning health system. But based on the findings in our report, it is a serious problem—and one that is not being effectively addressed. ONC looks forward to working with Congress, industry, and the health IT community to properly address this problem and ensure continued progress towards achieving the goals of an interoperable learning health system.

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) launched the Designated Test EHR Program more than one year ago, which has essentially been part of the Stage 2 Meaningful Use transition of care objective. This measure requires eligible hospitals, eligible professionals, and critical access hospitals to electronically exchange a summary of care document with a recipient who has differently designed EHR technology developed by another vendor, according to the Office of the National Coordinator for Health IT (ONC).

A second option for eligible hospitals and professionals is to take part in successful testing through the CMS Designated Test EHR Program during the EHR reporting period. ONC recently announced that Epic Systems and Cerner Corporation have decided to participate in the CMS Designated Test EHR Program along with iPatientCare.

During a prior year, Meditech and McKesson also participated in the program. While Epic Systems and Cerner Corporation have joined, a number of vendors dropped out including Athena Health, Meditech, and McKesson. Previously, Athena Health had participated in the pilot before the finalized program launch and was not a CMS Designated Test EHR vendor during the launch.

Currently, more than 5,000 healthcare providers have successfully attested to the transition of care meaningful use objective after conducting the relevant tests. The majority of providers, however, prefer the first option for meeting this particular meaningful use objective – exchanging summary of care information with a provider who has an EHR from a different technology developer.

Essentially, the second option is considered a “last resort” for providers who cannot meet this measure using the first option. Providers should be aware that this transition of care objective can be met at any point during the reporting year and not necessarily during the reporting period.

In order to assist eligible professionals and hospitals struggling to meet this objective, CMS released a FAQ sheet that outlines a solution. If providers are unable to participate in either option of this objective, they will need to provide documentation on their hardship and attest “yes” to meeting the measure as long as they are utilizing a certified EHR system capable of sending summary of care data and attaining the required standards.

“Designated Test EHRs will be registered on a software system, ‘EHR Randomizer’, hosted by the National Institute of Standards and Technology (NIST). The NIST-hosted software system will randomly match an EP, eligible hospital, or CAH with a designated test EHR that is designed by a different EHR technology developer than theirs,” ONC stated on its website.

Healthcare professionals who need to meet the transition of care objective under the Stage 2 Meaningful Use requirements now have the opportunity to test their summary of care exchange through Cerner and Epic technologies.

Currently, when healthcare data moves in this country it does it using fax machines and patient sneaker-nets. Automated digital interoperability is still in its earliest stages, mostly it has a history of being actively resisted by both the EHR vendors and large healthcare providers. We, as an industry, should be doing better, and our failure to do so is felt everyday by patients across the country.

Both of these plans ignore the lessons in execution from the previous strategic plan for health IT from ONC. The current Interoperability Roadmap mentions the “NwHIN” (Nationwide Health Information Network) for instance, and only covers what it accomplished, which are mostly policy successes like the DURSA (Data Use and Reciprocal Support Agreement). NwHIN was supposed to be a network of networks that connected every provider in the country… why hasn’t that happened?

ONC has forgotten what the actual ambition was in 2010. It was not to create cool policy documents. The plan 5 years ago was to have the “interoperability problem” solved in 5 years. The plan 5 years before that was probably to solve the problem in 5 years. Apparently, our policy makers look at interoperability and say “wow this is a big problem, we need at least 5 years to solve it”. Without any sense of ironic awareness that this is what they have been saying for decades, even before Kolodner was the ONC.

The silliness of this is that we need further planning on this at all. We don’t need a plan for interoperability, we need interoperability. We could just republish the old plan and it would work just as well if ONC executes and just as poorly if ONC does not execute. At what point do we start looking carefully at what has happened before and start saying “Why is this process not working better?” and “What can we do truly differently?”

The alternative to this deep and uncomfortable introspection is self delusion. Our industry has a very bad habit of rebranding rather than rethinking interoperability. Remember Community Health Information Networks (CHINs)? Those were “not sustainable”. So rather than find something that was “sustainable” we rebranded the same basic concepts as Regional Health Information Networks. But they typically failed too. Now the correct term for an unsustainable local exchange networks is a Health Information Exchange. See the problem here? No significant change in thinking or approach, just a rebranding, and the ushering in of a new generation of technology vendors. Swap out the old “bad” technology and protocols, and bring in the new. IHE is bad, we need SOAP. SOAP is bad, we need REST. The Direct Project is bad, we need Argonaut. CCR is bad we need CDA. CDA is bad we need FHIR. See the pattern here? We need to completely step back and ask uncomfortable questions about our overall approach to interoperability.

Patients, nurses and doctors in this country need more than a cursory examination of the issues behind health information exchange. We need to carefully compare and contrast what was said then, and what is being said now. We need to understand why this part of the system continues to fail.

Lets take a brief look at the “in summary our approach is” from the previous plan:

The Nationwide Health Information Network has already demonstrated sharing of patient-health information between the VA, DoD, SSA, and many private sector partners. Extending the Nationwide Health Information Network specifications with additional building blocks such as the Direct specifications will include protocols for provider patient secure messaging, which is a major step towards patient-centered care.

At the time, ONC was backing two protocols, the Direct Project and IHE (as implemented by CONNECT). Here you can see a video of the two protocols being promoted at the 2010 OSCON conference by the two project leaders at the time. Here I am doing essentially the same thing the next year, in 2011. I completely bought into that strategic plan.

Why didn’t those two projects solve the problems over the course of the next 5 years?

From the old strategic document again:

Nationally, the government is developing a standards and interoperability framework (S&I framework) to harmonize existing standards and improve sharing of standards across different organizations and federal agencies, making it easier to broaden interoperability through shared standards for data and services.

The S&I framework, and later Meaningful Use, would deeply endorse the CDA standard as a “harmonized” approach. Now the current roadmap has this to say about CDA:

Though much of the industry has implemented C-CDA as it is required in 2014 CEHRT and subsequently Meaningful Use stage 2, there is significant variability in the implementation of the standard.

Seeing the pattern again? CDA was supposed to be the harmonized standard, and now the industry needs a harmonized standard. This occurs in the “Moving Forward and Critical Actions” section immediately after a discussion of how the industry borked CDA:

HL7’s Fast Healthcare Interoperability Resources (FHIR) effort is one effort that is emerging and exploring ways to accommodate new methods of exchanging information.

During the Health IT ONC annual meeting (Feb 2015), the current ONC specifically held out hope that the Argonaut program was going to really address interoperability issues. (For those that do not know, Argonaut is a project to implement OAuth for a REST API based on SMART that delivers healthcare data using the FHIR standard).

So everybody now loves REST and FHIR.

And they are not wrong, FHIR embraces JSON rather than just XML and REST/OAuth has proven itself as the best way to do moder API implementations.

But FHIR and REST will not solve the problem of interoperability. They are just todays shiny toys that will end up having exactly the same problems that Direct and IHE currently face. The hard parts of interoperability have never been about technology, it has always been about forcing and industry that has substantial disincentives to do interoperability to do it anyway.

The problem is this: The Meaningful Use (MU) incentives have no realistic protocols in place for EHR vendors and EHR users to prove that they are generating compliant versions of the current standards. There are no real meaty required tests for compliance to existing standards. There are no meaty requirements to actually exchange data.

You need to maintain a three pronged approach to interoperability testing in order to ensure that interoperability is going to work.

Require extensive pass-fail interoperability testing for MU3 EHR certification, using simulated exchange scenarios. Ensure that those tests still work in the wild during attestation.

Require that MU attestation force end users of EHR systems to detail who they exchange data with and how, allow them to subjectively rate their EHR vendors support of their interoperability efforts during attestation.

Develop a “tattle tell” interoperability endpoint that can accept and automatically de-identify forwarded CDA/FHIR/whatever files that are the result of real health information exchange, so that “standards bad actors” can be detected in the wild.

Here are the steps required to do extensive pass-fail interoperability testing for MU3 EHR certification, using simulated exchange scenarios.:

Create 1000 different correctly formed CDA and FHIR files.

Design 100 different “treatments” that can be broadly applied to all 1000 profiles. (i.e. “add content showing the patient just had a new HIV test come back positive”, or “add content showing the patient has a new blood pressure reading of whatever/whatever”

Create 100,000 “end states” that represent how the 1000 start states should be transformed by the 100 “treatments”.

In order to achieve MU3 certification, an EHR vendor must demonstrate the ingestion of all 1000 start states encoded in CDA, and properly model all 100 “treatments” on each profile, generating 100,000 different end states, which are then exported to CDA and run through a testing engine that accepts one and only one CCA configuration per test.

During attestation, EHR users will have to inject 6 simulated patient records, and perform 6 “treatments” properly and then send those 6 to the MU testing portal. Those simulated patients should both delivered and retrieved under all approved HIE transfer protocols, including Direct, IHE and Argonaut.

Then, during attestation, the MU portal should leverage the latest version of the DocGraph referral dataset to determine which 10 NPIs the submitting provider has the most shared patients with, who also have MU certified EHRs. Then simply ask who among those 10 providers they are exchanging data with, and how.

Attestors should also be asked to rate their vendors support of their interoperability efforts (from 1-6…provide no option for “neutral”, cause we all know that is a cop-out and if it is available every attestor will choose it).

If attestors are not communicating with the providers they share patients with, then they should not be given Meaningful Use dollars.

If vendors are constantly resisting their customers efforts to exchange data their certifications should be revoked.

You cannot police whether interoperability is functioning without measuring it in the real world, and attestation is your primary tool for measuring what is happening in the market.

This proposal will be unpopular with providers, who will lament that their MU dollars are now dependent on the willingness of others to exchange data with them. But if HHS wants to ensure that its billions of dollars in EHR investment are resulting in Health Information Exchange, it needs to ensure that the exchange is actually working.

It is critical that neither vendors nor users be in a position to “either/or” their way out of real interoperability. Providers choose not to allow patients to communicate with them using Direct, because they could “either/or” give them access to patient data using a portal. All of the HL7 standards have more ‘ors’ than a viking warship.

But “options” is only part of the problem. Even when options have been narrowed and standards are explicit, “in the wild” variation is still common and problematic. As a result, the third component of a “real” interoperability system is a “tattle tell system”. ONC should create a mechanism for providers to upload actual CDA/FHIR/Whatever files that they have gotten from their partners. They should be able to tag those files as being sent from specific EHR systems and version numbers, as well as tagging them with which healthcare providers sent them.

The tattle tale system should immediately de-identify the relevant files, and then pass them through the standards compliance guantlet. ONC has already invested in solid technology to test compliance, and these should be leveraged here. You should publish report cards showing standards compliance by both provider and EHR vendor basis. There should be a “self-testing mode” that is not publicly reported that will allow EHR vendors and providers to test their own file generation process, without fear of repercussion. Vendors and providers should be able to rely on the deidentification logic of this testing service to ensure that they are able to test accurately without sharing PHI unnecessarily.

Part of me feels silly spelling out the details of how these systems should work at this level of detail. Indeed, my specific technical recommendations might need to be tweaked in order to work. But I am providing the detail to illustrate that what I am suggesting is technically possible. But technically possible and bureaucratically viable are two different things.

If ONC wants to support six transport protocols and five data standards, then ALL of those need to supported by ALL end users of EHR systems. If that seems unrealistic (hint.. it is unrealistic) then ONC needs to make tough decisions regarding supported protocols. Because of the walled garden problem (which I have commented on before and will again), Argonaut cannot be a lone transport protocol. You need to support both freedom to move data at patient preference (Direct) and support ease of development against EHRs as a platform (Argonaut). I see no reason why ONC needs to support more than two interoperability standards.

Make no mistake, ONC can either be popular or it can solve the interoperability problem. If you want to be popular, continue to use the word “or” a lot. There are “ors” all over the current implementation standards. In fact, I would like to give the award for “Captain Understatement” to whoever wrote the phrase there is significant variability in the implementation of the standard. That is some priceless phrasing…

Yet within the document, I take most issue with this paragraph:

In some cases the implementation guides provide sufficient clarity, specific implementation instructions and reduce the potential for implementation variability to a minimum. In other cases, further work is necessary among SDOs [Standards Development Organizations] to further refine implementation guidance as well as to develop best practices to improve implementation consistency among health IT developers.

It is clear that no amount of implementation guides are going to get this problem solved. Our industry ignores good implementation guides right along with bad implementation guides. As long as the EHR industry has the opportunity to flub interoperability, it will. EHR vendors and healthcare providers both have a huge motivation to not have interoperability work; as interoperability makes them both vendors and providers fireable. Patients who can move healthcare records around can switch doctors. Doctors who can move healthcare records around can switch EHR vendors. The Health IT industry needs to have comprehensive pass/fail testing that both the EHR vendors and their users have to conform to. ONC needs an ACID test for every interoperability standard it promotes. Then it needs to find a way to inject that ACID test into the real world as much as possible

We do not need more standards or better standards. We need ONC to arbitrarily enforce one single interpretation of the current standards. If ONC wants to change standards, go crazy with that, but in the end we need one single interpretation of those new standards.

If you want to make something change in the real world, it must be measured in the real world. The EPA spends lots of energy getting water samples in the real world. ONC needs to find ways to do the same thing. If the EPA changes its standards for what water quality should be in lakes and rivers, it then enforces those standards by measuring in the wild to ensure that they are properly enforced. The previous philosophy of the ONC has been so hands-off regarding testing that it would be equivalent to the EPA saying “we are going to totally change the standards for water quality in the United States, but we are going to halt our measuring program”. Obviously that would not work, and that is precisely why previous standards have not worked.

Some people feel that ONC does not have a congressional mandate to do the kind of interoperability testing that I am suggesting. But it does. ONC has a congressional mandate to get interoperability to work, and the only way to get interoperability to work is to do extensive, real-world testing. That is the only reasonable interpretation of this mandate.

Current electronic health record systems lack adequate laboratory data graphing capabilities, according to a study published in the Journal of the American Medical Informatics Association, Modern Healthcare reports.

Study Details

For the study -- which sought to determine the abilities of various EHR systems to display test results -- researchers analyzed eight EHR systems based on 11 criteria.

Of the eight EHR systems included in the study, six had been certified by the Office of the National Coordinator for Health IT, including those from:

Allscripts;

Cerner;

eClinicalWorks;

Epic;

Meditech; and

Partners Longitudinal Medical Record.

The other systems were the Department of Veterans Affairs' Computerized Patient Record System and Glassomics, an EHR prototype designed to work with Google Glass.

The study did not rate the EHR systems by name.

Findings

Overall, the researchers found none of the systems met all 11 criteria.

According to the study, the highest-rated system achieved 10 of 11 criteria, while the lowest-rated system achieved five.

The most common problem among EHR systems was the failure to label the vertical, or Y-axis.

Other flaws included:

An EHR system that labeled data in reverse order with the most recent data on left instead of the right;

An EHR system that did not equally space out data points on graphs, which could result in an erroneous slope when measuring rates; and

Three systems that did not include patient identification directly on the graphs.

According to EHR Intelligence, the results showed a lack of standardized workflows among EHR systems, which could lead to an increase in medical errors and a decline in patient safety.

When the Centers for Medicare & Medicaid Services published its final rule for Stage 2 meaningful use on Aug. 29, it trumpeted the "flexibility" it offered for how providers can use certified electronic health records.

Specifically, the rule allowed providers to use the 2011 Edition certified EHRs, or a combination of 2011 and 2014 Edition technology for the reporting period in 2014. By 2015, all eligible professionals, eligible hospitals, and critical access hospitals are required to use the 2014 Edition certified IT.

“We listened to stakeholder feedback and provided CEHRT flexibility for 2014 to help ensure providers can continue to participate in the EHR Incentive Programs forward,” said CMS Administrator Marilyn Tavenner, in a press statement.

But industry groups did not feel listened-to. And they definitely did not see much in the way of flexibility – at least when it came to reporting periods – a topic on which they'd lobbied particularly hard.

"CHIME is deeply disappointed in the decision made by CMS and ONC to require 365-days of EHR reporting in 2015," said Russell P. Branzell, chief executive officer of the College of Healthcare Information Management Executives, in a press statement responding to the new rule.

"This means that penalties avoided in 2014 will come in 2015, and millions of dollars will be lost due to misguided government timelines," he added. "Now, the very future of meaningful use is in question."

Other stakeholders were similarly wary of CMS' next steps. Even the day before that final rule, MGMA Policy Advisor Robert Tennant (perhaps intuitively sensing what it would contain), told Healthcare IT News that, "We've raised numerous concerns about where meaningful use is going. If significant changes are not coming in the program, I think the program risks a lot. We could see, frankly, failure of the program."

In mid-September, CHIME, MGMA and more than a dozen other stakeholders joined forces to write a pointed letter to HHS Secretary Sylvia Mathews Burwell – Tavenner and National Coordinator for Health IT Karen DeSalvo, MD, were CC'd – to reiterate their serious concern that the success of meaningful use "hinges on addressing the 2015 reporting period requirements.

While the groups – which included HIMSS, the American Medical Association, the American Hospital Association and more – thought their concerns had been heard and would be acknowledged in the Aug. 29 rule, they "were surprised to learn that flexibilities meant to mitigate 2014 challenges did not also address program misalignment in 2015 and beyond."

The numbers speak for themselves, the groups argued. As of September, just 143 hospitals and 3,152 providers have been able to meet Stage 2 with 2014 Edition EHRs.

"This represents less than 4 percent of the hospitals required to be Stage 2-ready within the next 15 days," according to the letter. "And while eligible professionals have more time, they are in comparatively worse shape, with only 1.3 percent of their cohort having met the Stage 2 bar thus far."

While the stakeholders reiterated their commitment to meaningful use, they urged Secretary Burwell to "take immediate action by shortening the 2015 EHR reporting period to 90 days" – and also by adding more wiggle room with regard to Stage 2's notoriously troublesome transitions of care and view/download/transmit measures.

The very next day, a new bi-partisan bill seeking to offer providers meaningful relief was drafter on Capitol Hill. Republican North Carolina Congresswoman Renee Ellmers introduced H.R. 5481, The Flexibility in Health IT Reporting (Flex-IT) Act of 2014, on Sept. 16.

Co-sponsored with Democratic Utah Rep. Jim Matheson, the new legislation is crafted to offer providers more flexibility in showing meaningful use compliance. Specifically, according to Ellmers' office, it would remedy HHS' "short-sighted final rule" requiring 365 days of EHR reporting in 2015.

The Flex-IT Act would allow providers to report their technology upgrades in 2015 through a 90-day reporting period as opposed to a full year. It would be welcome relief for legions of providers, who say the shortened reporting window would help them better manage meaningful use's many onerous mandates.

"The meaningful use program has many important provisions that seek to usher our health care providers into the digital age," said Ellmers in a press statement. "But instead of working with doctors and hospitals, HHS is imposing rigid mandates that will cause unbearable financial burdens on the men and women who provide care to millions of Americans. Dealing with these inflexible mandates is causing doctors, nurses, and their staff to focus more on avoiding financial penalties and less on their patients."

By giving providers the option to choose any three-month quarter for the EHR reporting period in 2015 to qualify for MU, "hundreds of thousands of providers" would have a better shot of meeting Stage 2 requirements safely and effectively, she said.

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